Surgical headpiece

ABSTRACT

A headpiece for use on a surgical patient being subjected to at least one specific site surgical procedure comprising a body portion defining an interior volume for receiving at least a portion of the patient&#39;s head, the body portion having an edge at least partially defining an opening for receiving the portion of the patient&#39;s head and a sign on the headpiece identifying at least one specific surgical site, e.g., right side, on the patient where the surgical procedure is to be performed.

FIELD OF THE INVENTION

The present invention relates to an apparatus, more specifically a headpiece, to reduce the likelihood of wrong-site surgery on a patient.

BACKGROUND OF THE INVENTION

A great amount of attention has recently been given to the unacceptable rate of avoidable patient injuries, or so-called medical mistakes in the United States. Estimates of the number of medical mistakes per year in the United States is difficult to ascertain, but a recent publication, To Err is Human by Dr. Lucian Leape, suggests that the avoidable death rate from medical mistakes is between 48,000 and 96,000 patients per year. One avoidable medical mistake is wrong-site surgery (WSS) which is defined as:

-   -   (a) the wrong operation performed on the patient,     -   (b) an operation performed on the wrong patient, or     -   (c) an operation performed on the wrong body part.

Because it is characterized as a preventable medical error, great efforts have been made to reduce the incidents of WSS. Current methodologies to prevent WSS include the use of indelible markers and adhesive labels to identify appropriate surgical sites. These methodologies have inherent deficiencies and WSS continues to occur. A zero-tolerance policy for WSS has been mandated by major agencies and professional organizations that accredit healthcare providers. Therefore, a need exists for still better ways to further reduce the likelihood of WSS.

SUMMARY OF THE INVENTION

In one embodiment, the apparatus of the present invention comprises a headpiece or hat to be worn by a patient that is to undergo or is undergoing a surgical procedure characterized as being site specific, e.g., a right-side procedure, a left-side procedure, or a bilateral procedure. The headpiece of the present invention comprises a body portion forming an interior volume for receipt of at least a portion of the patient's head. The headpiece further includes a sign on the headpiece, e.g., the body portion, providing information identifying the correct site(s) upon which the surgical procedure(s) is/are to be performed.

The foregoing objects, features and advantages of the present invention, as well as others, will be more fully understood and better appreciated by reference to the following drawings, specification and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is perspective view of one embodiment of the headpiece of the present invention in bouffant form wherein the sign on the headpiece indicates a right side surgical procedure is to be performed.

FIG. 2 is a fragmentary view of the body portion of the headpiece of FIG. 1 showing the letter R superimposed on a red background, the combination of the letter R and the red color forming the sign.

FIG. 3 is a view similar to FIG. 2 showing a fragmentary depiction of a body portion of the headpiece shown in FIG. 5 showing the letter L superimposed on a green background, the combination of the letter L and the green color forming the sign.

FIG. 4 is a view similar to FIGS. 2 and 3 shows the letter B superimposed on a blue background as the sign and combination of the letter B and the blue color forming a sign indicating a bilateral procedure.

FIG. 5 is a view similar to FIG. 1 but showing the headpiece having a fitted body portion with the sign described in FIG. 3.

FIG. 6 is a fragmentary view of a portion of the headpiece of FIG. 5 showing the use of ties to secure or fasten the headpiece to the patient's head.

FIG. 7 is a fragmentary view of the portion of the headpiece of FIG. 5 showing the use of an elastic band or strand in the headpiece of the present invention to secure or fasten the headpiece to the patient's head; and

FIG. 8 is a view similar to FIGS. 6 and 7, showing another embodiment of the present invention wherein the headpiece employs mating Velcro pieces to secure or fasten the headpiece of the present invention to the patient's head.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring first to FIG. 1, there is shown the head and upper portion of a patient P wearing a headpiece, shown generally as 10, according to the present invention. As is well know, during surgery and generally just prior thereto, the patient who is undergoing or is to undergo the surgical procedure is typically fitted with a headpiece, the purpose of which is to prevent hair or other contaminants from escaping from the head of the patient during the surgical procedure. The headpiece 10 shown in FIG. 1 is of the bouffant style having a body portion 12 made of a lightweight, flexible material described more fully hereafter, the body portion 12 being sufficiently large and flexible for accommodating variously sized and irregularly shaped hairdos. As depicted more clearly in FIG. 7, headpiece 10 has an edge, shown generally as 14, which at least partially defines an opening for receiving the patient's head to be covered by the body portion 12 and in the specific embodiment shown in FIGS. 1 and 7 defines what may be characterized as a headband portion 16, headband portion 16 encircling the patient's P head. Headband 16 can form a channel 18 which can be formed by a continuous spiral or series of separate rings of thread sewn along edge 14. Alternatively, channel 18 can be formed by simply overlapping the lower edge 14 and sewing it back onto the body portion 12. In any event, forming part of headband 14 of headpiece 10 is an elastic strand 20 which in the embodiment shown in FIGS. 1 and 7 completely encircles the head of the patient P, i.e., it is annular as is headband 16.

It is to be understood that the term “headband” as used herein in connection with the type of headpieces to which the invention is directed will typically comprise simply an edge of the body portion which can have an elastic strand, either completely encircling the opening form by the edge of the headpiece or only a portion of the edge as the case may be. By way of example, the headband referred to in the description herein and the claims is not intended to mean a construction of any particular size, shape or construction, but rather is simply to refer to that portion of the surgical cap which at least partially defines the opening into which the patient's head fits into the body portion. Thus, the headband can comprise simply the edge of the body portion which defines the opening, the edge in combination with an elastic strand, etc.

Referring now to FIG. 5, there is shown another embodiment of the headpiece of the present invention wherein the patient P₁ is wearing a headpiece shown generally as 22 which, rather than having a body portion that is bouffant in nature, has a body portion 24, also made of a lightweight, flexible material, which has a lesser internal volume than headpiece 10 to more closely fit to the head of the patient P₁. Unlike the embodiment of the invention shown in FIGS. 1 and 7, headpiece 22, rather than employing an elastic band 20 as shown in the headband 16 of the embodiment shown in FIGS. 1 and 7, employs a pair of ties 26 and 28 which are attached to ends 30 and 32, respectively, of the headband 34 affixed to the edge, shown generally as 36, of body portion 24. In this regard, the body portion 24 has a split 38 which form ends 30 and 32 and allows ties 26 and 28 to be drawn tightly together so as to fasten or secure the headpiece 22 to the patient P₁ head.

FIG. 8 shows another embodiment of the present invention, wherein the body portion of the headpiece 40, which could be the bouffant type shown in FIG. 1 or of the more snugly fitting cap type shown in FIG. 5, has a slit 42 such that the edge, shown generally as 43, forming the headband 45 of the headpiece shown in FIG. 8 has first and second ends 44 and 46 which are secured together by mating strips of Velcro, a first mating strip 48 of Velcro being on first end 44, a second mating strip of Velcro 50 being on end 46.

FIGS. 6, 7 and 8, thus show three of any number of various types of retainers or securing device which can be employed to retain or secure the headpiece of the present invention on the patient's head generally by compressing the edge of the body portion forming the opening into which the patient P head fits on the head of the patient.

As noted above, one of the purposes of the headpiece of the present invention is to aid in preventing WSS. More specifically, the headpiece of the present invention is a further aid in ensuring that surgical procedures will be performed at the appropriate site, e.g., on the left side, on the right side or in appropriate cases bilaterally. There are numerous surgical procedures which are performed on either the right or left side of a patient and less frequently in a bilateral manner. For example, surgical procedures on extremities such as knee surgery, foot surgery, hand surgery, ankle surgery, etc., are typically performed on either the right or left side of the patient but, in certain cases, may be bilateral, i.e., performed on both sides. Numerous other surgeries can be considered “right handed,” “left handed,” or “bilateral” such as ear surgery, eye surgery, hip surgery, hernia surgery, breast surgery, lung surgery, kidney surgery, etc.

The headpiece of the present invention is designed to minimize WSS by providing further notice to the preoperative and operative staff which surgical site, e.g., right site, left site, or bilateral sites, the surgery or surgeries is to be performed. To this end, the headpiece of the present invention which is to be worn by the patient being prepared for the surgical procedure and/or during the surgical procedure is provided with a sign which provides information about and/or identifies at least one specific surgical site, e.g., right side, left side, or bilateral, on the patient where the surgical procedure or procedures are to be performed.

The word “sign” as used herein is intended to encompass its broadest possible meaning as, for example, any perceptible indicator regardless of whether the indicator communicates to the perceiver visually, audibly, by touch, smell, or any other sense. The sign, which will be on some portion of the headpiece and more generally on the body portion thereof, can comprise a grapheme, a phoneme, a logogram, a color or any combination thereof. When the grapheme is the letter of an alphabet, the alphabet may be the Latin alphabet, the Cyrillic alphabet, the Arabic alphabet, or the Brahmic alphabet. In addition, the grapheme may constitute a written symbol for sounds and language as letters of the alphabet is a character in picture writing as in Japanese kanji. As is well known, graphemes include letters of alphabets, Chinese ideograms, numerals, punctuation marks and other symbols. As noted above, the sign can be a sound and comprise a phoneme. Such phonemes can be generated by miniature chips carried by the headpiece which emit a sound conveying the desired information regarding the appropriate site for the surgical procedure. For example, chips which emit the sound “right” together with a grapheme which has the letter “R” could be used on the headpiece to indicate that the surgical procedure is to be performed on the right side. In similar fashion, a chip emitting the sound “bi” together with a grapheme comprising the letter “B” on the headpiece would convey to the preoperative and operative team a bilateral procedure. In the case of logograms which are generally defined as a written symbol representing an entire word or phrase without indicating its pronunciation, various numerals could be employed as, for example, the number “1” meaning right side, the number “2” meaning left side, the number “3” representing bilateral. Obviously logograms in combination with graphemes could be employed as well as logograms in combination with phonemes. Although the sign employed could be made to be universal such that regardless of the country or language spoken, the sign conveyed the appropriate surgical site, it will be apparent that specific signs could be employed for different countries, for different languages, for different cultures, etc. For example, Chinese characters could be employed in countries and/or cultures using only such, a letter from the Cyrillic alphabet in cultures employing only that alphabet, etc.

Color is another sign that is readily adaptable to the present invention, particularly since a color or color combination quickly becomes universally recognizable as having a certain meaning, e.g., a red light in a traffic system as indicating “stop,” a green light in a traffic system as indicating “go,” etc. However, because of color blindness in some individuals, a color or color combination alone may not suffice and thus some of the other signs mentioned above can be employed. It is also believed that a particularly useful sign is the combination of a color and a grapheme, e.g., the letter “L” and a given color, e.g., green for left side procedures, the letter “R” and a given color, e.g., red for right side procedures, the letter “B” and a given color, e.g., blue for bilateral procedures. One of the advantages of using a grapheme/color combination, is after some degree of use, the color of the combination will become associated with a specific site surgical procedure, e.g., right, left or bilateral, while the grapheme will serve as confirmation.

In more sophisticated versions of the headpiece of the present invention, the sign can comprise not only some perceptible indication of the specific surgical site or sites, e.g., right, left, etc., but a simplified simulation of the body part on which the surgical procedure is to be performed. For example, with reference to FIG. 1 and assuming that the surgical procedure was to be performed on the right leg of the patient, a simplified depiction of a leg could be included together with the letter “R” whether with or without a specific color as shown.

It will be recognized from the above, that the “sign” contemplated by the present invention, can include a myriad of indicators in virtually any form with the requirement that the sign indicate at least one surgical site in the sense of being “right,” “left,” or “bilateral.”

The sign can, as shown for example in FIGS. 1 and 5, comprise a multiplicity of individual signs, i.e., randomly or regularly spaced letter “R,” “L,” or “B” on the headpiece, primarily on the body portion or could include only one sign on the headpiece. For easy viewing and minimizing confusion, it is generally more practical to have a multiplicity of signs, whether randomly or evenly distributed on the headpiece.

The material of the headpiece, at least of the body portion thereof is typically of a lightweight, thin, flexible material and can include a wide variety of materials, typically used in making such surgical or bouffant caps. Thus materials such as non-woven or plastic films, paper, paper/plastic composites, spunbonded fabric, etc., can be used. In general, the materials of construction of the headpiece of the present invention are not important since other than preventing hair or other contaminants on the head of the patient from entering the surgical site or into the operating theatre; no particular other functions are expected from the headpiece. Accordingly, the headpieces of the present invention would typically be made of the most economical material, be it paper, plastic or a mixture thereof, which accomplishes the aforementioned function of preventing the escape of contaminants from the patient's head during the surgical procedure. Additionally, since the headpieces are disposable, one size fits all headpieces, economy of construction is desired. In regard to size, it will be apparent that while “one size fits all” is generally the case for adults; the headpiece can be made in smaller sizes for children or, for that matter, any number of sizes. Also, since in most cases the retainer is adjustable, size is generally not a problem.

The foregoing description and examples illustrate selected embodiments of the present invention. In light thereof, variations and modifications will be suggested to one skilled in the art, all of which are in the spirit and purview of this invention. 

1. A headpiece for use on a surgical patient being subjected to at least one specific site surgical procedure comprising: a body portion defining an interior volume for receiving at least a portion of said patient's head, said body portion having an edge at least partially defining an opening for receiving said portion of said patient's head; and at least one sign on said headpiece identifying at least one specific surgical site on said patient where said surgical procedure is to be performed.
 2. The headpiece of claim 1, further including a retainer for retaining said body portion on said at least a portion of said patient's head.
 3. The headpiece of claim 1, wherein said body portion is bouffant.
 4. The headpiece of claim 1, wherein said body portion is fittable to said portion of said patient's head.
 5. The headpiece of claim 1, wherein said edge defines at least a part of a headband portion at least partially encircling said patient's head.
 6. The headpiece of claim 5, wherein said headband portion is annular.
 7. The headpiece of claim 6, wherein said headband portion includes an elastic member.
 8. The headpiece of claim 7, wherein said elastic member is annular.
 9. The headpiece of claim 5, wherein said headband portion extends for only a portion of said opening.
 10. The headpiece of claim 9, wherein there is an elastic member in said headband portion.
 11. The headpiece of claim 5 wherein there is a retainer for retaining said body portion on said at least a portion of said patient's head.
 12. The headpiece of claim 11, wherein said headband portion comprises first and second ends.
 13. The headpiece of claim 12, wherein said retainer comprises first and second mating strips of Velcro, said first, mating strip of Velcro being attached to said first end, said second, mating strip of Velcro being attached to said second end.
 14. The headpiece of claim 12, wherein said retainer comprises first and second ties attached to said first and second ends.
 15. The headpiece of claim 1, wherein said sign is on said body portion.
 16. The headpiece of claim 1, wherein said sign comprises a grapheme.
 17. The headpiece of claim 16, wherein said grapheme comprises a letter of an alphabet.
 18. The headpiece of claim 1, wherein said sign comprises a phoneme.
 19. The headpiece of claim 1, wherein said sign comprises at least one color.
 20. The headpiece of claim 1, wherein said sign is selected from the group consisting of graphemes, phonemes, colors, logograms and combinations thereof.
 21. The headpiece of claim 1, wherein said sign comprises the combination of a color and a grapheme.
 22. The headpiece of claim 1, wherein said sign comprise at least one character of an alphabet.
 23. The headpiece of claim 22, wherein said alphabet is selected from the group consisting of the Latin alphabet, the Cyrillic alphabet, the Arabic alphabet, the Brahmic alphabet and combinations thereof.
 24. The headpiece of claim 1, wherein said sign comprises a logogram.
 25. The headpiece of claim 16, wherein said grapheme is selected from the group consisting of letters, Chinese characters, Japanese characters, numerals, punctuation marks, and combinations thereof.
 26. The headpiece of claim 1, wherein said body portion is made of a flexible material. 